ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE
NCT ID: NCT03296150
Last Updated: 2024-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
139 participants
INTERVENTIONAL
2018-03-29
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being.
ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Development of an Evaluation Method of Elderly Condition in Patient Receiving Chemotherapy Treatment
NCT00210249
Observational Study to Assess Adherence Oral Anticancer Therapies
NCT03195972
Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy
NCT04327583
Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients with Risk Factors
NCT03257969
Pharmacist-led Intervention on Adherence in Patients Undergoing Treatment With an Oral Oncology Medication
NCT03104114
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control arm : Information
Patients will receive the usual standard information delivered to patients
No interventions assigned to this group
Intervention arm : Therapeutic educational program
Patients will receive the therapeutic educational program "PRESTAGE"
PRESTAGE
PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PRESTAGE
PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For which oral anticancer therapy has been initiated within the previous 45 days or will be started within 45 days
* For any type of cancer, solid or hematologic, any stage
* Estimated life expectancy\> 6 months
* Affiliation to social security or equivalent
* Patients who can answer questionnaires and protocol evaluations
* Informed consent signed by patients
* Domiciled within 50 km around the investigating center
Exclusion Criteria
* First-generation Hormone Therapy in Prostate Cancer
* Patient not available for regular follow-up whatever the cause (geographic, family, social, psychological)
* Any serious condition, ie serious physical or mental, leading to a disability permanent and likely to prevent the proper course of treatment
* Patient deprived of liberty or under guardianship
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olivia LE SAUX
Role: STUDY_CHAIR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL
Bron, , France
Service de Gériatrie, Centre Hospitalier de Givors
Givors, , France
Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole
La Tronche, , France
Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL
Lyon, , France
Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL
Lyon, , France
Service d'oncologie médicale, Cnetre Léon Bérard
Lyon, , France
Service d'oncologie, Centre Hospitalier Annecy Genevois
Metz-Tessy, , France
Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)
Pierre-Bénite, , France
service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
69HCL16_0149
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.